FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

Heidelberg Pharma AG, a clinical-stage biopharmaceutical company developing innovative Antibody Drug Conjugates (ADCs), announced that its lead Amanitin-based ADC candidate, HDP-101 (pamlectabart tismanitin), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma. 

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety, tolerability, and antitumor activity of HDP-101 in patients who have not responded to prior therapies. 

Professor Andreas Pahl, Chief Executive Officer of Heidelberg Pharma, stated: “We are very pleased to receive Fast Track Designation from the FDA, which underscores the potential of HDP-101 as a novel treatment option for patients with multiple myeloma who face significant unmet medical needs. This designation will enable closer collaboration with the FDA and help us advance the clinical development of HDP-101 more efficiently toward these patients.” 

The Fast Track Designation program is designed to facilitate the development and expedite the review of drugs that treat serious or life-threatening conditions and address unmet medical needs. The designation provides sponsors with increased access to FDA guidance, eligibility for Rolling Review of the Biologics License Application (BLA), and potential qualification for Priority Review or Accelerated Approval. 

HDP-101 (pamlectabart tismanitin) is an investigational ADC targeting BCMA (B-cell maturation antigen), conjugated with Heidelberg Pharma’s proprietary Amanitin payload technology. It is currently being evaluated in a clinical trial and has not yet received marketing approval from any regulatory authority. The safety and efficacy of HDP-101 have not been established.